Sigma Spectrum Infusion Pump Model 35700: Class 1 Recall: Risk of Over-Infusion
MedSun: Newsletter #74, July 2012

FDA MedWatch Safety Alert

Expanded Class I Recall-Serial numbers range from 700000 through 794213. All pumps serviced by SIGMA after September 21, 2010, or remediated as part of the initial recall notification, and all pumps manufactured after November 1, 2010, are not affected by this expanded recall. These units may fail suddenly causing inaccurate flow conditions during use, ranging from back flow to over-infusion, including free flow. The pump does not issue an alarm when this occurs. These conditions could result in serious injury or death.

Additional Information:

FDA MedWatch Safety Alert. Sigma Spectrum Infusion Pump Model 35700: Class 1 Recall: Risk of Over-Infusion. June 15, 2012.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm233747.htm


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